Professional Documents
Culture Documents
RECOMMENDATIONS INCLUDE:
METHODS OF ANALYSIS
QUALITY ASSURANCE
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Recommendations
© SWGDRUG 2008-10-01 – All rights reserved ii
Contents Page
Foreword……………………………………………………………………………………. vi
Introduction………………………………..……………………………………………...… vii
Core committee…………………………………………………………………………….. viii
Recommendations
© SWGDRUG 2008-10-01 – All rights reserved iii
3.4 Initial training requirements…………………………………………………..…… 19
3.5 Maintaining competence……………………………………………..……………. 20
4 Physical plant…………………………………………………………………….….20
5 Evidence control………………………………………………………………..….. 20
5.1 Receiving and identifying evidence……………………………………….……… 20
5.2 Integrity of evidence…………………………………………………………….…. 21
5.3 Storage of evidence…………………………………………………………….…..21
5.4 Disposition of evidence……………………………………………………………. 21
5.5 Documentation retention procedures………………………………………….….21
6 Analytical procedures………………………………………………………..…….. 21
6.1 Analytical procedures for drug analysis…………………………………….…….21
6.2 Verification of drug reference materials…………………………………………..22
7 Instrument/Equipment performance……………………………………..………. 22
7.1 Instrument performance…………………………………………………………… 22
7.2 Equipment…………………………………………………………………..………. 23
8 Chemicals and reagents……………………………………………………..……. 23
9 Casework documentation, report writing and review……………………………23
9.1 Casework documentation…………………………………………………………. 23
9.2 Report writing……………………………………………………………………….. 24
9.3 Case review………………………………………………………………………… 24
10 Proficiency and competency testing…………………………………………..…. 24
10.1 Proficiency testing………………………………………………………………….. 25
10.2 Competency testing……………………………………………………………..…. 25
11 Analytical method validation and verification……………………………………. 25
12 Laboratory audits……………………………………………………………………25
13 Deficiency of analysis……………………………………………………………… 26
14 Health and safety……………………………………………………………….….. 26
14.1 Health and safety requirements……………………………………………….…..27
15 Additional documentation…………………………………………………….…… 27
Recommendations
© SWGDRUG 2008-10-01 – All rights reserved iv
PART IV C – Quality Assurance/Uncertainty
1 Introduction…………………………………………………………………………. 35
2 Qualitative analysis………………………………………………………………… 36
3 Quantitative measurements………………………………………………………. 36
4 Estimation of measurement uncertainty for quantitative determinations…….. 37
4.1 Sources of uncertainty for weight determinations………………………………. 37
4.2 Sources of uncertainty for purity determinations……………………………….. 37
4.3 Factors relevant to estimation of measurement uncertainty…………………... 37
4.4 Approaches for estimation of measurement uncertainty………………………. 38
5 Reporting of uncertainty…………………………………………………………… 39
5.1 Reporting……………………………………………………………………………. 39
5.2 Reporting Examples……………………………………………………………….. 39
6 Training……………………………………………………………………………… 40
7 References………………………………………………………………………….. 41
Bibliography………………...……………………….…………………………………..…..52
Recommendations
© SWGDRUG 2008-10-01 – All rights reserved v
Foreword
This publication contains recommendations from the Scientific Working Group for the
Analysis of Seized Drugs (SWGDRUG). These recommendations are intended to
assist forensic analysts and managers in the development of analytical techniques,
protocols and policies. They are recognized to be minimum standards that may be
modified to address unique jurisdictional requirements. SWGDRUG seeks to have these
recommendations internationally accepted as the foundation for good laboratory
practice. These recommendations encompass Code of Professional Practice,
Education and Training, Methods of Analysis and Quality Assurance. The SWGDRUG
Core Committee strongly urges the adoption of these recommendations by any
laboratory involved in the analysis of seized drugs.
Since 1997, SWGDRUG has been working to provide useful and practical
recommendations for the analysis of seized drugs. SWGDRUG recognizes that over
time these recommendations may need to be updated as a result of advances in
technology, changes in accreditation requirements and/or the emergence of new
requirements. To this end, SWGDRUG relies heavily of the input of the forensic
community to ensure that all recommendations remain useful and current. This
synergetic approach is a key component of the SWGDRUG process. I encourage
everyone to continue supporting the mission of SWGDRUG.
Finally, as the Chairman of SWGDRUG, I would be remiss if I did not single out several
individuals within whom SWGDRUG would not exist. Benjamin A. Perillo, former
Deputy Assistant Administrator, DEA Office of Forensic Sciences, who conceived this
working group and made it a reality. Thomas J. Janovsky, Deputy Assistant
Administrator, DEA Office of Forensic Sciences and former Chairman of SWDRUG who
promoted and enhanced SWGDRUG’s prominence in the Forensic Community. Joseph
P. Bono, former Quality Assurance Manager, DEA Office of Forensic Sciences who
served as SWGDRUG secretariat from the beginning and handled all of the behind the
scene activities that made SWGDRUG a success. Lastly, Scott R. Oulton, Laboratory
Director, DEA Southwest Laboratory, for his untiring efforts in coordinating and
facilitating the SWGDRUG meetings.
I would also like to make special mention to the Office of National Drug Control Policy,
Counterdrug Technology Assessment Center and the National Institute of Standards
and Technology, which over the years have provided the financial resources for
SWGDRUG to operate.
Nelson Santos
Recommendations
© SWGDRUG 2008-10-01 – All rights reserved vi
Introduction
SWGDRUG is comprised of a core committee of more than 20 forensic scientists from
around the world. The mission of SWGDRUG is to recommend minimum standards for
the forensic examination of seized drugs and to seek their international acceptance.
SWGDRUG seeks to achieve this mission through the following objectives:
Drug abuse and trafficking in controlled substances are global problems, and in recent
years law enforcement has looked to international solutions for these problems. In 1997
the U.S. Drug Enforcement Administration (DEA) and the Office of National Drug
Control Policy (ONDCP) co-sponsored the formation of the Technical Working Group for
the Analysis of Seized Drugs (TWGDRUG). Forensic scientists from the United States,
England, Canada, Australia, Japan, Germany and the Netherlands, as well as
representatives of the United Nations, several international forensic organizations and
academia were invited to meet in Washington, DC. This group, with input from around
the world, developed recommendations for educational standards and professional
development for forensic practitioners. They also recommended quality assurance
standards for the analysis of seized drugs and minimum standards for their
identification. The name Scientific Working Group for the Analysis of Seized Drugs was
adopted in 1999.
SWGDRUG has received input from many forensic scientists in its standards
development process. It has used various methods of communication including its
Internet site (www.swgdrug.org), MICROGRAM, presentations at numerous local,
national and international meetings, and personal contacts. The Methods and Reports
subcommittee received over 300 responses to an international survey. Following each
meeting of the Core Committee, updates are published and distributed.
SWGDRUG sought and considered comments from the forensic science community on
all its proposals. In order for a recommendation to be adopted, there must be a quorum
of at least 3/4 of the membership and acceptance vote of 2/3 of the attending members
is required. Please refer to SWGDRUG’s bylaws, which can be found on the internet at
www.swgdrug.org/bylaws.htm for additional details.
Recommendations
© SWGDRUG 2008-10-01 – All rights reserved vii
In January 2005 the leadership of SWGDRUG was transferred to Nelson A. Santos,
Chair and Scott R. Oulton, Secretariat, after the many years of service from Mr.
Janovsky and Mr. Bono. The various sub-committees continue to research and develop
proposals for additional recommendations with several members completing their
service to the group and others replacing them by invitation. The following chart details
those persons who have rendered service as members of the core committee over the
years. For a list of current members, please reference the SWGDRUG website.
Core Committee
Ms. Susan Ballou Dr. Suzanne Bell
Office of Law Enforcement Standards West Virginia University
National Institute of Standards and Technology Morgantown, West Virginia
Gaithersburg, Maryland
Mr. Robert Bianchi Mr. Joseph Bono (Secretariat)
Drug Enforcement Administration Drug Enforcement Administration
McLean, Virginia Washington, DC
Dr. Michael Bovens Dr. Bob Bramley
Wissenschaftlicher Dienst Forensic Science Service
Zurich, Switzerland Birmingham, England
Dr. Sylvia Burns Mr. Gary Chasteen
Forensic Science Service Los Angeles County Sheriff's Laboratory
Birmingham, England Scientific Services Downey, California
Mr. Alan B. Clark Mr. Jeffrey H. Comparin (Secretariat)
Drug Enforcement Administration Drug Enforcement Administration
Washington, DC Dulles, VA
Dr. Alim A. Fatah Dr. Maria Eugenia Forero Ruiz National
Office of Law Enforcement Standards Institute Legal Medicine and Forensic Science
National Institute of Standards and Technology Bogota. Colombia
Gaithersburg, Maryland
Mr. Richard Gervasoni Ms. Jo Ann Given
Montgomery County Police Department Lab Naval Criminal Investigative Service
Rockville, Maryland Norfolk, Virginia
Mr. Garth Glassburg Ms. Dorothy Gordimer
Northeastern Illinois Regional Crime Union County Prosecutor’s Office Laboratory
Laboratory Westfield, New Jersey
Vernon Hills, Illinois
Ms. Kathleen Higgins Dr. Henk Huizer
Office of Law Enforcement Standards Ministry of Justice
National Institute of Standards and Technology Forensic Science Laboratory
Gaithersburg, Maryland Rijswijk, The Netherlands
Dr. Takako Inoue Ms. Linda Jackson
National Research Institute of Police Science Department of Forensic Science
Tokyo, Japan Richmond, Virginia
Mr. Thomas J. Janovsky (Chair) Dr. Tohru Kishi
Drug Enforcement Administration National Research Institute of Police Science
Washington, DC Chiba, Japan
Recommendations
© SWGDRUG 2008-10-01 – All rights reserved viii
Dr. Cherif Kouidri Mr. Richard Laing
United Nations International Drug Control Health Canada
Programme Drug Analysis Service Laboratory
Vienna, Austria Vancouver, Canada
Mr. Marc LeBeau Mr. John Lentini
Federal Bureau of Investigation Applied Technical Services, Inc.
Washington, DC Marietta, Georgia
Dr. Bruce Lodge Mr. David Martin
Health Canada Department of Forensic Science
Ottawa, Ontario Canada Richmond, Virginia
Mr. Jack Mario Dr. Yoshiteru Marumo
Suffolk County Crime Laboratory National Research Institute of Police Science
Hauppauge, New York Chiba, Japan
Mr. Jerry Massetti Mr. Christian Matchett
California Department of Justice California Georgia Bureau of Investigation
Criminalistics Institute Decatur, Georgia
Sacramento, California
Dr. Iphigenia Naidis Dr. Helmut Neuman
United Nations Office on Drugs and Crime Bundeskriminalamt
Vienna Austria Forensic Science Institute
Wiesbaden, Germany
Mr. Osamu Ohtsuru Mr. Robert Ollis
National Research Institute of Police Science Georgia Bureau of Investigation
Chiba, Japan Decatur, Georgia
Mr. Scott R. Oulton (Secretariat) Mr. Richard A. Paulas
Drug Enforcement Administration Illinois State Police Forensic Sciences
Vista, California Command
Chicago, Illinois
Mr. Benjamin Perillo Dr. Robert Powers
Drug Enforcement Administration Connecticut Department of Public Safety
Washington, DC Hartford, Connecticut
Ms. Cate Quinn Dr. Conrad Roberson
Victoria Police Forensic Services Department Georgia Bureau of Investigation
Melbourne, Australia Decatur, Georgia
Mr. Nelson A. Santos (Chair) Mr. Tshepo Shole
Drug Enforcement Administration National Forensic Science Laboratory
Washington, DC Pretoria, South Africa
Dr. Jay Siegel Dr. Erkki Sippola
Michigan State University National Bureau of Investigation
School of Criminal Justice Crime Laboratory
East Lansing, Michigan Vantaa, Finland
Mr. Zoran Skopec Dr. Howard Stead
Australian Forensic Drug Laboratory United Nations International Drug Control
Pymble, NSW, Australia Programme
Vienna, Austria
Recommendations
© SWGDRUG 2008-10-01 – All rights reserved ix
Dr. Charles "Chris" Tindall Ms. Erin Trujillo
Metropolitan State College of Denver Los Angeles County Sheriff’s Lab
Department of Chemistry Los Angeles, California
Denver, Colorado
Mr. Etienne van Zyl Ms. Eileen Waninger
National Forensic Science Laboratory Federal Bureau of Investigation Laboratory
Pretoria, South Africa Quantico, Virginia
Mr. Jaco Westraat Dr. Udo Zerell
National Forensic Science Laboratory Bundeskriminalamt
Pretoria, South Africa Forensic Science Institute
Wiesbaden, Germany
Recommendations
© SWGDRUG 2008-10-01 – All rights reserved x
PART I
PREFACE
This Code of Professional Practice has been written specifically for analysts. However,
it is important that their managers and the technicians and others who assist them in
their work are equally aware of its provisions, and they support the analyst in adhering
to these. Where appropriate, the provisions are also equally applicable to the
technicians in the approach to their own work.
1 Introduction
Analysts should:
2.2 Casework
Analysts should:
b) ensure that they have a clear understanding of what the customer needs
and all the necessary information, relevant evidential materials and
facilities available to reach a meaningful conclusion in an appropriate
timeframe;
d) make and retain full, contemporaneous, clear and accurate records of all
examinations and tests conducted, and conclusions drawn, in sufficient
detail to allow meaningful review and assessment of the conclusions by an
independent person competent in the field;
e) accept responsibility for all casework done by themselves and under their
direction;
f) conduct all professional activities in a way that protects the health and
safety of themselves, co-workers, the public and the environment.
2.3 Reporting
Analysts should:
1 Introduction
Part II recommends minimum education, training and experience for analysts practicing
in laboratories that conduct seized drug analyses. It describes the types of activities
necessary to continue professional development and reference literature required in
laboratories where they practice.
2.1 The aim of this recommendation is that all analysts recruited in the
future should have at least a bachelor’s degree, while allowing
existing analysts without degrees to be retained as analysts. The
minimum educational requirements for analysts are EITHER
OR
All forensic scientists have an ongoing responsibility to remain current in their field. In
addition, laboratories should provide support and opportunities for continuing
professional development. Minimum continuing professional development requirements
for a laboratory analyst are:
3.1 Twenty contact hours of training every year. Contact is defined as face-to-
face interaction with an instructor or trainer in a classroom or laboratory
setting. It does not include self-paced learning or distance education
where the instructor has no active interaction with the student.
3.4 Training can be provided from a variety of sources, including, but not
limited to the following:
4.2 Topic areas in the training program will include, as a minimum, the
following:
The following references and documents shall be available and accessible to analysts.
f) relevant jurisdictional legislation (e.g., statutes and case law relating to controlled
substances, and health and safety legislation)
1 Introduction
This document addresses minimum recommendations for sampling of seized drugs for
qualitative analysis; quantitative analyses will be addressed at a later time.
NOTE For the purpose of this document the use of the term “statistical” refers to “probability-based.”
Population Determination
Sampling Scheme
Hypergeometric
Bayesian
Statistical Other probability-based
Approaches
Sampling Plan Square root N
Non-Statistical Management Directive
Judicial Requirements
Sampling Procedure
A sampling strategy is highly dependent on the purpose of the investigation, the original
question, and the ultimate use of the results. Laws and legal practices form the
foundation of most strategies and shall be taken into account when designing a
sampling scheme. Therefore, specific sampling strategies are not defined in this
document.
2.1 The laboratory has the responsibility to develop its own strategies
consistent with these recommendations. SWGDRUG recommends
attention to the following key points:
3 Sampling scheme
Bulk Material
Is physical
or Bulk Multiple Dosage Bulk Material Visually no no Determine Total Population
separation into
Units? (E.g., Multi-kg, Homogeneous? to which sampling plan will
sub-groups possible?
multiple tablets) apply (e.g. total weight)
no
Is the
weight or volume
of selected units appropriate
no A
for analysis?
A
Is the
weight or volume
of the units appropriate
no yes
for analysis?
A
Is the
weight or volume
yes Analyze Selected Units of selected units appropriate no
for analysis?
yes
Analyze All Units
Return to
decision making
process
Insert A
3.1.1 The population determination shall take into account all typical
forms and quantities in which exhibits may appear.
3.1.3 A multiple unit population shall consist of items, which are similar in
relevant visual characteristics.
There are numerous sampling plans used in the forensic analysis of drugs, which
are applicable to single and multiple unit populations.
3.2.2 Depending upon the inference to be drawn from the analysis for a
multiple unit population, the sampling plan may be statistical or
non-statistical.
• Hypergeometric
o Frank et al., Journal of Forensic Sciences, 1991,
36(2) 350-357
o Guidelines on Representative Drug Sampling,
European Network of Forensic Science Institutes
(ENFSI), 2004, www.enfsi.org
o American Society for Testing and Materials (ASTM)
E-2334-03
• Bayesian
o Coulson et al., Journal of Forensic Sciences, 2001,
46(6) 1456-1461
o Guidelines on Representative Drug Sampling, ENFSI,
2004, www.enfsi.org
3.3.1 Establish the procedure for selecting the number of units that will
comprise the sample.
Sample reduction may be applied in cases where the weight or volume of the
selected units is too large for laboratory analysis (Figure 2, insert A).
4 Analysis
SWGDRUG recommends that each unit comprising the sample shall be analyzed
to meet the SWGDRUG minimum recommendations (Part III B) for forensic drug
identification, if statistical inferences are to be made about the whole population.
5 Documentation
Inferences drawn from the sampling plan and analyses shall be documented.
1 Introduction
The purpose of PART III B is to recommend minimum standards for the forensic
identification of commonly seized drugs. It is recognized that the correct identification of
a drug or chemical depends on the use of an analytical scheme based on validated
methods and the competence of the analyst. SWGDRUG requires the use of multiple
uncorrelated techniques. It does not discourage the use of any particular method within
an analytical scheme and it is accepted that unique requirements in different
jurisdictions may dictate the actual practices followed by a particular laboratory.
Techniques for the analysis of drug samples may be classified into three categories
based on their discriminating power. Table 1 provides examples of these techniques
listed in order of decreasing discriminating power from A to C.
Pharmaceutical Identifiers
Thin Layer
Chromatography
Cannabis only:
Macroscopic Examination
Microscopic Examination
3.1.1 This combination shall identify the specific drug present and shall
preclude a false positive identification.
3.1.2 When sample size allows, the second technique should be applied
on a separate sampling for quality assurance reasons. When
sample size is limited, additional measures should be taken to
assure that the results correspond to the correct sample.
3.1.3 All Category A techniques shall have data that are reviewable.
3.2 When a Category A technique is not used, then at least three different
validated methods shall be employed.
3.3 For the use of any method to be considered of value, test results shall be
considered “positive.” While “negative” test results provide useful
information for ruling out the presence of a particular drug or drug class,
these results have no value toward establishing the forensic identification
of a drug.
4 Comment
1 Introduction
It is the goal of a laboratory's drug analysis program to provide the customers of the
laboratory's services access to quality drug analysis. It is the goal of these
recommendations in PART IV A to provide a quality framework for management of the
processing of drug casework, including handling of evidentiary material, management
practices, analysis and reporting. These are minimum recommendations for practice.
The term “evidence” has many meanings throughout the international community. In
this document it is used to describe drug exhibits that enter a laboratory system.
2.1 Personnel responsible for this shall be clearly designated and shall have
direct access to the highest level of management concerning laboratory
policy.
2.2 The quality management system shall cover all procedures and reports
associated with drug analysis.
3 Personnel
The Job descriptions for all personnel should include responsibilities, duties and
required skills.
An individual (however titled) may be responsible for one or more of the following
duties:
3.3 Qualifications/Education
OR
4 Physical plant
4.1 Laboratories shall provide a healthy, safe and secure environment for its
personnel and operations.
5 Evidence control
Access to the evidence storage area shall be granted only to persons with
authorization and access shall be controlled. A system shall be established to
document a chain of custody for evidence in the laboratory.
6 Analytical procedures
6.1.5 Laboratories shall have and follow documented guidelines for the
acceptance and interpretation of data.
7 Instrument/Equipment performance
8.1 Chemicals and reagents used in drug testing shall be of appropriate grade
for the tests performed.
8.3 Documentation for reagents prepared within the laboratory shall include
identity, concentration (when appropriate), date of preparation, identity of
the individual preparing the reagents and the expiration date (if
appropriate).
8.5 Chemical and reagent containers should be dated and initialed when
received and also when first opened.
NOTE It is recognized that different jurisdictions may define competency and proficiency testing in a
manner other than how they are used here. In this context, competency tests measure the ability of the
analyst to produce accurate results. Proficiency tests are an ongoing process in which a series of
proficiency samples, the characteristics of which are not known to the participants, are sent to
laboratories on a regular basis. Each laboratory is tested for its accuracy in identifying the presence (or
concentration) of the drug using its usual procedures.
12 Laboratory audits
12.2 Records of each audit shall be maintained and should include the
scope, date of the audit, name of auditor(s), findings and any
necessary corrective actions.
13 Deficiency of analysis
In the course of examining seized drug samples and related materials, laboratories may
expect to encounter some operations or results that are deficient in some manner.
Each laboratory shall have a documented policy to address such deficiencies.
NOTE Deviations from established policy shall have documented management approval.
d) a requirement for evaluation of the impact the deficiency may have had
on other activities of the individual or other analysts;
NOTE It should be recognized that to be effective, the definition for "deficiency of analysis"
shall be relatively broad. As such, deficiencies may have markedly different degrees
of seriousness. For example, a misidentification of a controlled substance would be
very serious and perhaps require that either the methodology or the analyst be
suspended pending appropriate remedial action, as determined by management.
However, other deficiencies might be more clerical in nature, requiring a simple
correction at the first line supervisory level, without any suspension of methodology
or personnel. Thus, it may well be advantageous to identify the differing levels of
seriousness for deficiencies and make the action required be commensurate with the
seriousness.
15 Additional documentation
1 Introduction
1.2.2 For quantification the method should reliably determine the amount
of analyte present.
1.2.4 If non-routine validated methods are used, then the method shall be
verified prior to use.
All methods shall be validated or verified to demonstrate that they will perform in
the normal operational environment when used by individuals expected to utilize
the methods on casework.
• personnel involved
• dates
• observations from the process
• analytical data
• a statement of conclusions and/or recommendations
• authorization approval signature.
1.6 Recommendation
2.1 Purpose/scope
This is an introductory statement that will specify what is being tested, the
purpose of the testing and the result(s) required for acceptance.
State exactly the method to be validated. It is essential that each step in the
method be demonstrated to perform satisfactorily. Steps that constitute a
method for the identification and/or quantification of seized drugs may include:
2.4.1 Selectivity
Assess the impact of any interfering components and demonstrate that the
method works in the presence of substances that are commonly
encountered in seized drug samples (e.g. cutting agents, impurities, by-
products, precursors).
2.4.3 Recovery
2.4.4 Accuracy
2.4.4.2 Trueness
2.4.5 Range
Determine the concentration or sample amount limits for which the method
is applicable.
2.4.5.3 Linearity
2.4.7 Ruggedness
2.4.8 Uncertainty
3 Quality control
4 References
b) Federal Register, Part VIII, Department of Health and Human Services, March 1995,
pages 11259-62.
Quality Assurance/Uncertainty
1 Introduction
1.2 The term “uncertainty” does not imply doubt; rather, its consideration
provides assurance that results and conclusions from methods and
analytical schemes are fit for purpose.
1.6 Benefits
2 Qualitative Analysis
3 Quantitative Measurements
3.3 Primary numerical values reported in the analysis of seized drugs are
weight and purity. Where other values are measured (e.g., size, volume,
estimated tablet numbers), the same principles stated herein apply.
5 Reporting of uncertainty
5.1 Reporting
Uncertainty should be reported when it may impact the use of a result by the
customer. Factors which influence the decision to report uncertainty include:
5.1.1 Jurisdictional
6 Training
6.2 All analysts shall be capable of explaining their laboratory’s procedures for
evaluating uncertainty of qualitative and quantitative analyses.
7 References
7.5 Guide for the use of the International System of Units (SI), Taylor, B.N.,
National Institute of Standards and Technology, April 1995.
7.9 ISO 3534-1 Statistics — Vocabulary and symbols Part 1: Probability and
general statistical terms, ISO 3534-2 Statistics — Vocabulary and symbols
Part 2: Statistical quality control International Organization for
Standardization, Switzerland,1993.
A.1 Introduction
This glossary of terms and definitions has been developed and adopted by the
SWGDRUG core committee from a variety of sources that are listed in
endnotes. In some instances, the core committee modified existing definitions
or created definitions where none could be found in standard references.
A.2.1 accuracy
the closeness of agreement between a test result and the accepted reference value
NOTE The term accuracy, when applied to a set of test results, involves a combination of random
components and a common systematic error or bias component.
[ISO 3534-1:1993 (E/F)]
A.2.2 analyst
a designated person who:
• examines and analyzes seized drugs or related materials, or directs such
examinations to be done,
• independently has access to unsealed evidence in order to remove samples from
the evidentiary material for examination and,
• as a consequence of such examinations, signs reports for court or other purposes
[SWGDRUG]
A.2.3 analyte
the component of a system to be analyzed
[IUPAC]
A.2.4 audit
systematic, independent and documented process for obtaining audit evidence and
evaluating it objectively to determine the extent to which audit criteria are fulfilled
[ISO 9000:2005 (E)]
A.2.5 bias
the difference between the expectation of the test results and an accepted reference
value
NOTE Bias is the total systematic error as contrasted to random error. There may be one or more
systematic error components contributing to the bias. A larger systematic difference from the accepted
reference value is reflected by a larger bias value.
[ISO 3534-1:1993 (E/F)]
A.2.7 calibration
set of operations that establish, under specified conditions, the relationship between
values of quantities indicated by a measuring instrument or measuring system, or
values represented by a material measure or a reference material, and the
corresponding values realized by standards
NOTES
1. The result of a calibration permits either the assignment of values of measurands to the
indications or the determination of corrections with respect to indications.
2. A calibration may also determine other metrological properties such as the effect of influence
quantities.
3. The result of a calibration may be recorded in a document, sometimes called a calibration
certificate or a calibration report.
[ISO VIM]
NOTES
1. The definition of a “reference material certificate” is given in 4.2 (IVIM).
2. CRMs are generally prepared in batches for which the property values are determined within
stated uncertainty limits by measurement on samples representative of the whole batch.
3. The certified properties of reference materials are sometimes conveniently and reliably realized
when the material is incorporated into a specially fabricated device, e.g. a substance of known
triple-point into a triple-point cell; a glass of known optical density into a transmission filter;
spheres of uniform particle size mounted on a microscope slide. Such devices may also be
considered as CRMs.
4. All CRMs lie within the definition of measurement standards or etalons given in the International
vocabulary of basic and general terms in metrology (VIM).
5. Some RMs and CRMs have properties which, because they cannot be correlated with an
established chemical structure or for other reasons, cannot be determined by exactly defined
physical and chemical measurement methods. Such materials include certain biological
materials such as vaccines to which an International unit has been assigned by the World Health
Organization.
[ISO GUIDE 30:1992 (E/F), ISO VIM]
A.2.20 population
the totality of items or units of material under consideration
NOTE The word “items” may be interpreted in the sense of measurements, or possible measurements,
of a single characteristic, or occasionally for multiple characteristics, on all items or units of material being
considered. The word “totality” may refer to items not available for inclusion in samples as well as those
which are available.
[ASTM E456-04]
A.2.21 precision
the closeness of agreement between independent test results obtained under stipulated
conditions
NOTES
1. Precision depends only on the distribution of random errors and does not relate to the true value
or the specified value.
2. The measure of precision usually is expressed in terms of imprecision and computed as a
standard deviation of the test results. Less precision is reflected by a larger standard deviation.
3. “Independent test results” means results obtained in a manner not influenced by any previous
result on the same or similar test object. Quantitative measures of precision depend critically on
the stipulated conditions. Repeatability and reproducibility conditions are particular sets of
extreme stipulated conditions.
[ISO 3534-1:1993 (E/F)]
A.2.22 procedure
specified way to carry out an activity or process
NOTES
1. Procedures can be documented or not.
2. When a procedure is documented, the term “written procedure” or “documented procedure” is
frequently used. The document that contains a procedure can be called a “procedure document.”
[ISO 9000:2005 (E)]
NOTE Direction and control with regard to quality generally includes establishment of the quality policy
and quality objectives, quality planning, quality control, quality assurance and quality improvement.
[ISO 9000:2005 (E)]
NOTE Quality manuals can vary in detail and format to suit the size and complexity of an individual
organization.
[ISO 9000:2005 (E)]
NOTE – A reference material may be in the form of a pure or mixed gas, liquid or solid. Examples are
water for the calibration of viscometers, sapphire as a heat-capacity calibrant in calorimetry, and solutions
used to for calibration in chemical analysis.
[ISO GUIDE 30:1992, VIM]
NOTES
1. These conditions are called repeatability conditions.
2. Repeatability conditions include:
• the same measurement procedure
• the same observer
• the same measuring instrument, under the same conditions
• the same location
• repetition over a short period of time.
3. Repeatability may be expressed quantitatively in terms of the dispersion characteristics of the
results.
[VIM]
NOTES
1. A valid statement of reproducibility requires specification of the conditions changed.
2. The changed conditions may include:
• principle of measurement
• method of measurement
• observer
• measuring instrument
• reference standard
• location
• condition of use
• time.
[VIM]
A.2.34 robustness
the robustness of an analytical procedure is a measure of its capacity to remain
unaffected by small, but deliberate variations in method parameters and provides an
indication of its reliability during normal usage
[EURACHEM, ICH Q2A, CPMP/CH/381/95]
A.2.36 sample
one or more sampling units taken from a population and intended to provide information
on the population
NOTE A sample may serve as a basis for a decision on the population or on the process which
produced it.
[ISO 3534-1:1993 (E/F)]
A.2.37 sampling
the process of drawing or constituting a sample
[ISO 3534-1:1993 (E/F)]
NOTES
1. A criterion is, for example, that the number of nonconforming items is less than or equal to the
acceptance number.
2. The sampling plan does not contain the rules on how to take the sample.
[ISO 3534-2:1993 (E/F)]
NOTE Some schemes have switching rules for automatic change to tightened inspection plans or
reduced inspection plans or change to 100 % inspection.
[ISO 3534-2:1993 (E/F)]
A.2.43 traceability
ability to trace the history, application or location of that which is under consideration
NOTES
1. When considering product, traceability can relate to
• the origin of materials and parts,
• the processing history, and
• the distribution and location of the product after delivery.
2. In the field of metrology the definition in VIM:1993, 6.10, is the accepted definition.
[ISO 9000:2005 (E)]
A.2.44 trueness
the closeness of agreement between the average value obtained from a large series of
test results and an accepted reference value
NOTES
1. The measure of trueness is usually expressed in terms of bias.
2. Trueness has been referred to as “accuracy of the mean.” This usage is not recommended.
[ISO 3534-1:1993 (E/F)]
NOTES
1. Uncertainty of measurement comprises, in general, many components. Some of these
components may be estimated on the basis of the statistical distribution of the results of a series
of measurements and can be characterized by standard deviations. Estimates of other
components can only be based on experience or other information.
2. Uncertainty should be distinguished from an estimate attached to a test result which
characterizes the range of values within which the expectation is asserted to lie. This latter is a
measure of precision rather than of accuracy and should be used only when the true value is not
defined. When the expectation is used instead of the true value the expression “random
component of uncertainty” should be used.
[ISO 3534-1:1993 (E/F)]
NOTES
1. The term “validated” is used to designate the corresponding status.
2. The use conditions for validation can be real or simulated.
[ISO 9000:2005(E)]
A.2.48 verification
confirmation, through the provision of objective evidence, that specified requirements
have been fulfilled
NOTES
1. The term “verified” is used to designate the corresponding status.
2. Confirmation can comprise activities such as
• performing alternative calculations,
• comparing a new design specification with a similar proven design specification,
• undertaking tests and demonstrations, and
• reviewing documents prior to issue.
[ISO 9000:2005(E)]
A.3.1 ASTM E456-04 Standard Terminology Relating to Quality and Statistics Annual
Book of ASTM Standards 2005, Section Fourteen, General Methods and
Instrumentation, Vol 14.02 Published by the American Society For Testing And
Materials International USA.
A.3.3 EURACHEM, The Fitness for Purpose of Analytical Methods English Edition,
Developed by EURACHEM Working Group. Supported in part under contract
with UK Department of Trade and Industry as part of the National Measurement
System Valid Analytical Measurement (VAM) Programme 1998.
A.3.6 ISO GUIDE 30:1992 (E/F), GUIDE 30 Terms and definitions used in connection
with reference materials 2nd Ed., Published by the International Organization for
Standardization, Switzerland 1992.
A.3.9 IUPAC, Entries are from the online version of the IUPAC Compendium of
Chemical Terminology that mostly corresponds to the second edition (1997),
compiled by Alan D. McNaught and Andrew Wilkinson (Royal Society of
Chemistry, Cambridge, UK).
Annex A – Bibliography
Recommendations
© SWGDRUG 2008-10-01 – All rights reserved Page 52
A.3.11 UNDCP, GLOSSARY OF TERMS FOR QUALITY ASSURANCE AND GOOD
LABORATORY PRACTICES Published by The United Nations International
Drug Control Programme, Vienna 1995.
A.3.12 USP 28:2005, THE UNITED STATES PHARMACOPOEIA 28TH Rev. Published
by the United States Pharmacopoeial Convention Inc. USA 2005.
End of Document
Annex A – Bibliography
Recommendations
© SWGDRUG 2008-10-01 – All rights reserved Page 53